Aim:

This randomized controlled trial aimed to compare the effectiveness of virtual reality and progressive muscle relaxation exercise in reducing anxiety during the non-stress test (NST) and to evaluate their effects on maternal physiological parameters in high-risk pregnant women.

Materials and Methods:

The study was conducted as a randomized controlled trial between March 2025 and August 2025 at Kanuni Sultan Süleyman Training and Research Hospital with 126 high-risk pregnant women. Participants were randomly assigned to three groups (42 per group): virtual reality, progressive muscle relaxation exercise, and control group.

During NST monitoring, participants in the virtual reality group received VR headset-based immersive audiovisual stimulation, while participants in the progressive muscle relaxation group performed guided relaxation exercises. The control group received routine NST monitoring without any additional intervention.

Data were collected using the Informed Consent Form, Pregnant Woman Information Form, Non-Stress Test Follow-up Form, Physiological Parameters Follow-up Form, Visual Analog Scale (VAS), and State-Trait Anxiety Inventory (STAI Form TX-I). The STAI, VAS, and physiological parameters were measured before and after NST, while fetal NST parameters were recorded during the procedure.

Background and Rationale

Non-stress test (NST) is a commonly used antenatal surveillance method in high-risk pregnancies to evaluate fetal well-being. However, the procedure may increase maternal anxiety and discomfort due to prolonged immobility and concern about fetal health. Elevated anxiety during NST may also influence maternal physiological responses.

Non-pharmacological interventions such as virtual reality (VR) and progressive muscle relaxation exercise (PMRE) are increasingly used in clinical settings to reduce anxiety and improve physiological stability. VR provides immersive multisensory distraction through audiovisual stimulation, while PMRE reduces sympathetic nervous system activity through systematic muscle tension and relaxation cycles.

Although both interventions have been shown to reduce anxiety in different clinical populations, limited evidence exists comparing VR and PMRE within the same randomized controlled framework during NST in high-risk pregnant women.

Aim of the Study

The primary aim of this randomized controlled trial is to determine the effect of virtual reality and progressive muscle relaxation exercise on maternal anxiety during non-stress testing in high-risk pregnant women. The secondary aim is to evaluate their effects on maternal physiological parameters and fetal non-stress test outcomes.

Study Design

This study is a randomized controlled, parallel-group clinical trial with three arms: virtual reality group, progressive muscle relaxation group, and control group. A total of 126 high-risk pregnant women (42 per group) will be enrolled.

Randomization will be performed using a computer-generated randomization system (Randomizer.org). The study is open-label (no blinding).

Interventions

Virtual Reality Group:

Participants will wear a VR headset during the 20-minute NST procedure and will be exposed to immersive audiovisual environments (e.g., nature scenes, ocean waves, rainfall). Participants may select preferred environments. Audio intensity will be individually adjusted.

Progressive Muscle Relaxation Exercise Group:

Participants will receive guided PMRE during the 20-minute NST. The intervention includes sequential tensing and relaxing of major muscle groups while focusing on breathing and bodily sensations. Each muscle group will be tensed for approximately 10 seconds followed by a relaxation period of approximately 20 seconds.

Control Group:

Participants will receive standard NST care without any additional intervention.

Data Collection Procedures

All participants will complete the State-Trait Anxiety Inventory (STAI Form TX-I) and the Visual Analog Scale (VAS; 0-10, where 0 = no tension and 10 = extreme tension) immediately before and after the NST procedure.

Maternal physiological parameters including systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, and oxygen saturation will be measured immediately before and after NST using standard clinical devices.

Fetal outcomes including fetal heart rate, fetal movements, accelerations, decelerations, and NST reactivity status will be recorded during the 20-minute NST using standard NST monitoring equipment and standardized data collection forms.

Demographic and obstetric characteristics will be collected using a structured personal information form prior to the intervention.

Eligibility Criteria

Inclusion Criteria:

• Pregnant women aged ≥18 years
• Gestational age ≥28 weeks
• Singleton pregnancy
• Hospitalized in the Perinatology (High-Risk Pregnancy) Unit
• Undergoing routine NST
• Able to read, write, and understand Turkish
• Willing to participate and provide written informed consent

Exclusion Criteria:

• Cognitive, psychiatric, or communication disorders affecting participation
• Severe visual or hearing impairment
• Medical conditions preventing participation in VR or relaxation techniques (e.g., musculoskeletal disorders, severe respiratory conditions such as uncontrolled asthma)
• Administration of magnesium sulfate (MgSO₄) within the last 2 hours prior to NST
• Refusal to participate in the study

Recruitment

Participants will be recruited from the Perinatology Unit. Eligible patients will be informed about the study, and written informed consent will be obtained prior to enrollment.

Statistical Analysis

Data will be analyzed using SPSS version 22.0. Normality of distribution will be assessed using the Kolmogorov-Smirnov test. Continuous variables will be presented as mean ± standard deviation, and categorical variables as frequency and percentage.

Between-group comparisons will be performed using one-way ANOVA, followed by Tukey post-hoc tests for pairwise comparisons. Within-group pre- and post-intervention comparisons will be analyzed using repeated measures ANOVA. Statistical significance will be set at p < 0.05.

Inclusion Criteria

Participants who meet all of the following criteria will be eligible for inclusion:

• Aged 18 years or older;
• Able to read, write, and understand Turkish;
• At ≥28 weeks of gestation;
• Having a singleton pregnancy;
• Having eaten, emptied the bladder, and refrained from smoking and alcohol consumption for at least 2 hours before the non-stress test (NST) procedure;
• Diagnosed by a physician with a high-risk pregnancy, including but not limited to preeclampsia, gestational diabetes mellitus, gestational hypertension, chronic hypertension, type 1 or type 2 diabetes mellitus, decreased fetal movement, premature rupture of membranes, threatened preterm birth, intrauterine growth restriction (IUGR), small for gestational age (SGA), oligohydramnios, or polyhydramnios.

Exclusion Criteria

Participants meeting any of the following criteria will be excluded:

• Having a physical or mental condition that may impair communication;
• Having a medical condition that may prevent participation in the intervention (e.g., musculoskeletal disorders, asthma);
• Receiving magnesium sulfate (MgSO₄) treatment or having received MgSO₄ within the previous 2 hours.

Withdrawal Criteria

Participants will be withdrawn from the study if they:

• Request to withdraw or no longer wish to continue participation in the study;
• Are assigned to an intervention group and fail to participate in at least 80% of the intervention sessions.

High risk pregnant woman

Will not be disclosed for confidentiality reasons.